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Table 2 Categories of postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration between 2009 and 2012

From: Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Postmarketing commitment description No. (%)
Subject to reporting requirements under 506Ba Total
Yes Nob
New clinical trials 27 (30.3) 6 (2.5) 33 (10.0)
Complete or submit results from ongoing clinical trials 15 (16.9) 1 (0.4) 16 (4.8)
Observational studies and secondary analysesc 11 (12.4) 0 (0.0) 11 (3.3)
Other studiesd 36 (40.4) 235 (97.1) 271 (81.9)
Total 89 (26.9) 242 (73.1) 331
  1. aUnder section 506B of the Food and Drug Administration Modernization Act of 1997, FDA has the authority to monitor the progress of postmarketing studies concerning clinical safety, clinical efficacy, clinical pharmacology, or nonclinical toxicology, that applicants have agreed or are required to conduct
  2. bAnnual status reports to FDA could still be required under 21 CFR 314.81(b)(2)(viii) (drugs)
  3. cLonger follow-up or new analyses of data from existing trials or studies; submission of a final report for ongoing case-control, cross-sectional, or retrospective cohort studies
  4. dManufacturing, stability, and immunogenicity studies without a primary safety endpoint; pharmacoepidemiologic studies; pharmacokinetic and/or pharmacodynamics trials; and chemistry, manufacturing, and controls study commitments that pharmaceutical companies have agreed with the FDA to conduct